Positioning of darunavir/cobicistat-containing antiretroviral regimens in real life: Results from a large multicentre observational prospective cohort (SCOLTA)

on behalf of CISAI Study Group, L. Taramasso, Elena Ricci, Antonio Cascio, Laura Valsecchi, B. Menzaghi, N. Squillace, Paolo Maggi, G. V. De Socio, Chiara Dentone, G. Madeddu, Giovanni F. Pellicanò, L. Calza, Goffredo Angioni, Paolo Bonfanti, Antonio Di Biagio

Research output: Contribution to journalArticle

Abstract

Background: Study aim was to evaluate the safety and durability of darunavir/cobicistat (DRV/c) in a real life setting. Methods: Multicentre prospective cohort study performed in the context of SCOLTA (Surveillance Cohort Long-Term Toxicity Antiretrovirals). Patients were evaluated at baseline, week 24 and 48. Changes were evaluated using the paired t test or signed rank test. The multivariable analysis was performed using a general linear model, after ranking of not normally distributed variables. Results: A total of 249 patients were included, 72 (29%) were in DRV/c-based dual therapies (DT). Hypercholesterolemia, HC, (total cholesterol (TC) ≥ 200 mg/dL or low density-C (LDL-C) ≥ 130 or statin use) was present in 121 (48.6%) and hypertriglyceridemia, (triglycerides (TG) ≥ 200 mg/dl or fibrate use) in 41 (16.5%) patients. Blood lipid profile did not change significantly in either the global population or patients with HC. After a median observation of 17 months (IQR 13-20), 59 (25.3%) patients discontinued DRV/c, of which 13 were in DT. The durability DT resulted higher than that of triple therapy (log-rank test p = 0.01). Main reasons for stopping DRV/c were simplification (15 patients), adverse events (13 patients), planned discontinuation for treatment initiation with DAA (4 patients), treatment failure (2 patients); death (2 patients), other causes (10 patients). Twenty-six were lost to follow-up. Conclusions: DRV/c was safe and well tolerated. Dual therapies showed a better profile of tolerability and a longer durability compared to triple therapies.

Original languageEnglish
Article number21
JournalAIDS Research and Therapy
Volume16
Issue number1
DOIs
Publication statusPublished - Aug 26 2019

Fingerprint

Therapeutics
Cobicistat
Darunavir
Fibric Acids
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypertriglyceridemia
Lost to Follow-Up
Hypercholesterolemia
Treatment Failure
Linear Models
Triglycerides
Cohort Studies
Cholesterol
Observation
Prospective Studies
Lipids
Safety
Population
oxidized low density lipoprotein

Keywords

  • Adverse events
  • CISAI
  • Darunavir/cobicistat
  • Dual
  • Durability
  • Tolerability

ASJC Scopus subject areas

  • Molecular Medicine
  • Virology
  • Pharmacology (medical)

Cite this

Positioning of darunavir/cobicistat-containing antiretroviral regimens in real life : Results from a large multicentre observational prospective cohort (SCOLTA). / on behalf of CISAI Study Group ; Taramasso, L.; Ricci, Elena; Cascio, Antonio; Valsecchi, Laura; Menzaghi, B.; Squillace, N.; Maggi, Paolo; De Socio, G. V.; Dentone, Chiara; Madeddu, G.; Pellicanò, Giovanni F.; Calza, L.; Angioni, Goffredo; Bonfanti, Paolo; Di Biagio, Antonio.

In: AIDS Research and Therapy, Vol. 16, No. 1, 21, 26.08.2019.

Research output: Contribution to journalArticle

on behalf of CISAI Study Group, Taramasso, L, Ricci, E, Cascio, A, Valsecchi, L, Menzaghi, B, Squillace, N, Maggi, P, De Socio, GV, Dentone, C, Madeddu, G, Pellicanò, GF, Calza, L, Angioni, G, Bonfanti, P & Di Biagio, A 2019, 'Positioning of darunavir/cobicistat-containing antiretroviral regimens in real life: Results from a large multicentre observational prospective cohort (SCOLTA)', AIDS Research and Therapy, vol. 16, no. 1, 21. https://doi.org/10.1186/s12981-019-0236-0
on behalf of CISAI Study Group ; Taramasso, L. ; Ricci, Elena ; Cascio, Antonio ; Valsecchi, Laura ; Menzaghi, B. ; Squillace, N. ; Maggi, Paolo ; De Socio, G. V. ; Dentone, Chiara ; Madeddu, G. ; Pellicanò, Giovanni F. ; Calza, L. ; Angioni, Goffredo ; Bonfanti, Paolo ; Di Biagio, Antonio. / Positioning of darunavir/cobicistat-containing antiretroviral regimens in real life : Results from a large multicentre observational prospective cohort (SCOLTA). In: AIDS Research and Therapy. 2019 ; Vol. 16, No. 1.
@article{14047871458f4245a767a80f7bdca19f,
title = "Positioning of darunavir/cobicistat-containing antiretroviral regimens in real life: Results from a large multicentre observational prospective cohort (SCOLTA)",
abstract = "Background: Study aim was to evaluate the safety and durability of darunavir/cobicistat (DRV/c) in a real life setting. Methods: Multicentre prospective cohort study performed in the context of SCOLTA (Surveillance Cohort Long-Term Toxicity Antiretrovirals). Patients were evaluated at baseline, week 24 and 48. Changes were evaluated using the paired t test or signed rank test. The multivariable analysis was performed using a general linear model, after ranking of not normally distributed variables. Results: A total of 249 patients were included, 72 (29{\%}) were in DRV/c-based dual therapies (DT). Hypercholesterolemia, HC, (total cholesterol (TC) ≥ 200 mg/dL or low density-C (LDL-C) ≥ 130 or statin use) was present in 121 (48.6{\%}) and hypertriglyceridemia, (triglycerides (TG) ≥ 200 mg/dl or fibrate use) in 41 (16.5{\%}) patients. Blood lipid profile did not change significantly in either the global population or patients with HC. After a median observation of 17 months (IQR 13-20), 59 (25.3{\%}) patients discontinued DRV/c, of which 13 were in DT. The durability DT resulted higher than that of triple therapy (log-rank test p = 0.01). Main reasons for stopping DRV/c were simplification (15 patients), adverse events (13 patients), planned discontinuation for treatment initiation with DAA (4 patients), treatment failure (2 patients); death (2 patients), other causes (10 patients). Twenty-six were lost to follow-up. Conclusions: DRV/c was safe and well tolerated. Dual therapies showed a better profile of tolerability and a longer durability compared to triple therapies.",
keywords = "Adverse events, CISAI, Darunavir/cobicistat, Dual, Durability, Tolerability",
author = "{on behalf of CISAI Study Group} and L. Taramasso and Elena Ricci and Antonio Cascio and Laura Valsecchi and B. Menzaghi and N. Squillace and Paolo Maggi and {De Socio}, {G. V.} and Chiara Dentone and G. Madeddu and Pellican{\`o}, {Giovanni F.} and L. Calza and Goffredo Angioni and Paolo Bonfanti and {Di Biagio}, Antonio",
year = "2019",
month = "8",
day = "26",
doi = "10.1186/s12981-019-0236-0",
language = "English",
volume = "16",
journal = "AIDS Research and Therapy",
issn = "1742-6405",
publisher = "BioMed Central",
number = "1",

}

TY - JOUR

T1 - Positioning of darunavir/cobicistat-containing antiretroviral regimens in real life

T2 - Results from a large multicentre observational prospective cohort (SCOLTA)

AU - on behalf of CISAI Study Group

AU - Taramasso, L.

AU - Ricci, Elena

AU - Cascio, Antonio

AU - Valsecchi, Laura

AU - Menzaghi, B.

AU - Squillace, N.

AU - Maggi, Paolo

AU - De Socio, G. V.

AU - Dentone, Chiara

AU - Madeddu, G.

AU - Pellicanò, Giovanni F.

AU - Calza, L.

AU - Angioni, Goffredo

AU - Bonfanti, Paolo

AU - Di Biagio, Antonio

PY - 2019/8/26

Y1 - 2019/8/26

N2 - Background: Study aim was to evaluate the safety and durability of darunavir/cobicistat (DRV/c) in a real life setting. Methods: Multicentre prospective cohort study performed in the context of SCOLTA (Surveillance Cohort Long-Term Toxicity Antiretrovirals). Patients were evaluated at baseline, week 24 and 48. Changes were evaluated using the paired t test or signed rank test. The multivariable analysis was performed using a general linear model, after ranking of not normally distributed variables. Results: A total of 249 patients were included, 72 (29%) were in DRV/c-based dual therapies (DT). Hypercholesterolemia, HC, (total cholesterol (TC) ≥ 200 mg/dL or low density-C (LDL-C) ≥ 130 or statin use) was present in 121 (48.6%) and hypertriglyceridemia, (triglycerides (TG) ≥ 200 mg/dl or fibrate use) in 41 (16.5%) patients. Blood lipid profile did not change significantly in either the global population or patients with HC. After a median observation of 17 months (IQR 13-20), 59 (25.3%) patients discontinued DRV/c, of which 13 were in DT. The durability DT resulted higher than that of triple therapy (log-rank test p = 0.01). Main reasons for stopping DRV/c were simplification (15 patients), adverse events (13 patients), planned discontinuation for treatment initiation with DAA (4 patients), treatment failure (2 patients); death (2 patients), other causes (10 patients). Twenty-six were lost to follow-up. Conclusions: DRV/c was safe and well tolerated. Dual therapies showed a better profile of tolerability and a longer durability compared to triple therapies.

AB - Background: Study aim was to evaluate the safety and durability of darunavir/cobicistat (DRV/c) in a real life setting. Methods: Multicentre prospective cohort study performed in the context of SCOLTA (Surveillance Cohort Long-Term Toxicity Antiretrovirals). Patients were evaluated at baseline, week 24 and 48. Changes were evaluated using the paired t test or signed rank test. The multivariable analysis was performed using a general linear model, after ranking of not normally distributed variables. Results: A total of 249 patients were included, 72 (29%) were in DRV/c-based dual therapies (DT). Hypercholesterolemia, HC, (total cholesterol (TC) ≥ 200 mg/dL or low density-C (LDL-C) ≥ 130 or statin use) was present in 121 (48.6%) and hypertriglyceridemia, (triglycerides (TG) ≥ 200 mg/dl or fibrate use) in 41 (16.5%) patients. Blood lipid profile did not change significantly in either the global population or patients with HC. After a median observation of 17 months (IQR 13-20), 59 (25.3%) patients discontinued DRV/c, of which 13 were in DT. The durability DT resulted higher than that of triple therapy (log-rank test p = 0.01). Main reasons for stopping DRV/c were simplification (15 patients), adverse events (13 patients), planned discontinuation for treatment initiation with DAA (4 patients), treatment failure (2 patients); death (2 patients), other causes (10 patients). Twenty-six were lost to follow-up. Conclusions: DRV/c was safe and well tolerated. Dual therapies showed a better profile of tolerability and a longer durability compared to triple therapies.

KW - Adverse events

KW - CISAI

KW - Darunavir/cobicistat

KW - Dual

KW - Durability

KW - Tolerability

UR - http://www.scopus.com/inward/record.url?scp=85071637093&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85071637093&partnerID=8YFLogxK

U2 - 10.1186/s12981-019-0236-0

DO - 10.1186/s12981-019-0236-0

M3 - Article

C2 - 31451115

AN - SCOPUS:85071637093

VL - 16

JO - AIDS Research and Therapy

JF - AIDS Research and Therapy

SN - 1742-6405

IS - 1

M1 - 21

ER -